COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES
FDA premarket approval P080011/S009 · decided 2012-02-24
Approval details
- PMA number
- P080011
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-01-26
- Decision date
- 2012-02-24
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR AN ADDITIONAL DENSITY CHECK OF THE LENS EXTRACTION/HYDRATION TANKS.
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